The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter.

It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, though the exact impact will not be clear immediately.

Here’s a look at the issues involved.

WHAT IS NARCAN?

The approved branded nasal spray from Gaithersburg, Maryland-based Emergent BioSolutions is the best-known form of naloxone.

It can reverse overdoses of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone.

Making naloxone available more widely is seen as a key strategy to control the nationwide overdose crisis, which has been linked to more than 100,000 U.S. deaths a year. The majority of those deaths are tied to opioids, primarily potent synthetic versions such as fentanyl that can take multiple doses of naloxone to reverse.

Advocates believe it’s important to get naloxone to the people who are most likely to be around overdoses, including people who use drugs and their relatives.

Police and other first responders also often carry it.

___

WHAT DOES THE FDA APPROVAL MEAN?

Narcan will become available over-the-counter by late summer, the company said.

Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon.

The nonprofit Harm Reduction Therapeutics Inc., which has funding from OxyContin maker Purdue Pharma, has an application before the FDA to distribute its version of spray naloxone without a prescription.

___

HOW IS NALOXONE DISTRIBUTED NOW?

Even before the FDA’s action, pharmacies could sell naloxone without a prescription because officials in every state have allowed it.

But not every pharmacy carries it. And buyers have to pay for the medication — either with an insurance co-pay or for the full retail price. The cost varies, but two doses of Narcan often go for around $50.

Story continues

The drug is also distributed by community organizations that serve people who use drugs, though it’s not easily accessible to everyone who needs it.

Emergent has not announced its price and it’s not clear yet whether insurers will continue to cover it as a prescription drug if it’s available over the counter.

___

DOES MAKING NALOXONE OVER-THE-COUNTER IMPROVE ACCESS?

It clears the way for Narcan to be made available in places without pharmacies — convenience stores, supermarkets and online retailers, for instance.

Jose Benitez, the lead executive officer at Prevention Point Philadelphia, an organization that tries to reduce risk for people who use drugs with services including handing out free naloxone, said it could help a lot for people who don’t seek services — or who live in places where they’re not available.

Now, he said, some people are concerned about getting naloxone at pharmacies because their insurers will know they’re getting it.

“Putting it out of the shelves is going to allows people just to pick it up, not have stigma attached to it and readily access this life-saving drug,” he said.

But it remains to be seen how many stores will carry it and what the prices will be. The U.S. Centers for Medicaid and Medicare Services, which now cover prescription naloxone for people on the government insurance programs, says that coverage of over-the-counter naloxone would depend on the insurance program. The centers have not given any official guidance.

Maya Doe-Simkins, a co-director of Remedy Alliance/For The People, which launched last year to provide low-cost — and sometimes free — naloxone to community organizations, said her group will continue to distribute injectable naloxone.

___

ARE THERE DRAWBACKS TO OVER-THE-COUNTER SALES?

One concern is whether people who buy Narcan over-the-counter will know how to use it properly, said Keith Humphreys, a Stanford University addiction expert, though the manufacturer is responsible for clear directions and online videos on that.

One benefit of having pharmacists involved, he said, is that they can show buyers how to use it. One key thing people need to be reminded of: Call an ambulance for the person receiving naloxone after it’s been administered.

He also said there are fears that if the drug isn’t profitable as an over-the-counter option, the drugmaker could stop producing it.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Geoff Mulvihill, The Associated Press

Adblock test (Why?)

Source link

A newly released survey finds nearly all Canadian adults had antibodies against COVID-19 for about half of 2022, with most acquiring them through a previous infection.

The results, released Tuesday by Statistics Canada in partnership with the Public Health Agency of Canada and COVID-19 Immunity Task Force, show that 98.1 per cent of Canadian adults living in the country’s 10 provinces had antibodies against SARS-CoV-2, the virus that causes COVID-19, between April and August 2022.

These individuals acquired antibodies through either vaccination, previous infection or both.

Over that five-month period, 53.9 per cent developed antibodies through a past infection.

This is in comparison to the results of a previous version of the survey done between November 2020 and April 2021 that found 2.6 per cent of Canadians had COVID-19 antibodies due to a previous infection.

A report detailing the findings says while almost 54 per cent of Canadians surveyed had antibodies from an infection, the actual proportion of those infected since the start of the pandemic is likely higher.

“This is due, in part, to the fact that an antibody response to an infection may not always be detectable, especially among those who are vaccinated who may generate fewer antibodies following a subsequent infection. In addition, antibody levels can decrease over time,” the report says.

ANTIBODIES

The survey used a technique known as dried blood spot testing to detect COVID-19 antibodies from vaccination or a past infection, as well as saliva samples to determine a current or recent infection.

A total of 105,998 people were chosen to participate in the survey, of which 30.7 per cent completed a questionnaire asking about general health and exposure to COVID-19. Of those who completed the questionnaire, nearly 54 per cent provided a blood sample and 54.5 per cent provided a saliva sample.

The body produces antibodies to defend against diseases and in response to vaccination.

However, they do decrease over time and the report says some people previously infected with COVID-19 or who have been vaccinated may no longer have detectable levels of antibodies.

But while antibodies may decrease with time, the report says it does not mean a person’s immunity has waned.

Rather, an individual may have developed cell-mediated immunity, which activates specialized white-blood cells called T cells.

The report says dried blood spot testing also does not measure cell-mediated immunity.

Even without detectable antibodies, the report adds that cell-mediated immunity could be enough to protect someone against severe COVID-19 symptoms. The mere presence of antibodies alone also isn’t enough to suggest a person could fend off a new infection or any serious symptoms.

MANY UNAWARE THEY WERE INFECTED

The survey found as many as two out of five Canadians with antibodies from a previous infection were unaware they had been infected, either because they never tested positive or did not suspect an infection.

Among those who previously tested positive for COVID-19, antibody levels were higher between 14 and 90 days post-infection before gradually decreasing over time.

“While this is indicative of decreasing antibodies, there are other factors which could impact this analysis,” the report says.

“For example, since vaccines may lead to a lesser antibody response following an infection, the percentage of Canadians with antibodies from infection may be affected by changing vaccination rates over time. Further, since the survey focuses on first infections, re-infections would also impact this analysis as these could lead to a rebound in antibody levels.”

Canadians with a disability or underlying health conditions were less likely to have antibodies from a previous infection compared to those who did not report a disability or health condition.

Those 18-34 and 35-49 were also more likely to have antibodies from a previous infection than older Canadians were.

Antibody levels from infection varied between population groups, ranging from as low as 53 per cent for Chinese Canadians to as high as 80.7 per cent for Black Canadians.

Across provinces, Nova Scotia had the lowest proportion of residents who developed antibodies from infection at 46.5 per cent, while Quebec (56.5 per cent), Alberta (57.4 per cent) and Saskatchewan (57.4 per cent) had the highest rates.

The survey did not include data from the three territories, those under 18 or people living on reserve, in institutions or Canadian Forces Bases.

Source link

(Bloomberg) — Healthy children and adolescents may no longer need Covid shots, the World Health Organization said, updating its guidance on vaccines as the world adjusts to living permanently with the virus.

Older people and higher-risk groups — including those with underlying conditions — should get Covid boosters between six and 12 months after their last injections, the WHO said in a statement announcing a revised vaccine road map for the new stage of the pandemic.

“Countries should consider their specific context in deciding whether to continue vaccinating low-risk groups, like healthy children and adolescents, while not compromising the routine vaccines that are so crucial for the health and well-being of this age group,” said Hanna Nohynek, chair of the WHO’s Strategic Advisory Group of Experts on Immunization.

The Geneva-based organization’s latest advice comes as booster rates fall in countries from China to the US, with just 16% of Americans lining up for the latest round of shots targeting the omicron variant, Bloomberg reported earlier this month.

The dropoff won’t just have financial consequences for vaccine makers — including Pfizer Inc. and Moderna Inc. — but is also sparking concerns among public health experts who say updated vaccinations are the best way to protect against Covid.

Read more: Covid Boosters Sour for Pfizer, Moderna With Uptake Rate at 16%

Healthy children between the ages of 6 months and 17 years are a low-priority group for vaccination, the WHO said, and primary and booster doses are safe and effective for them. They have typically experienced less severe reactions to Covid than adults.

The WHO said context mattered in deciding whether to inoculate younger people given the lower burden of disease.

The organization “urges countries considering vaccination of this age group to base their decisions on contextual factors, such as the disease burden, cost effectiveness, and other health or programmatic priorities and opportunity costs,” the statement said.

–With assistance from Tanaz Meghjani.

Source link